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Optimized Management of Endovascular Treatment for Acute Ischemic Stroke
Published on: January 18, 2018
Ischemic stroke survivors' opinion regarding research utilizing exception from informed consent
Dawn Kleindorfer1, Christopher J Lindsell, Kathleen Alwell
1University of Cincinnati, Cincinnati, Ohio 45267-0525, USA. dawn.kleindorfer@uc.edu
Cerebrovascular Diseases (Basel, Switzerland)
|September 17, 2011
Summary
Most ischemic stroke survivors agree to research enrollment without consent, but older patients, Black individuals, and women showed lower agreement rates for invasive procedures. This highlights patient perspectives on exception from informed consent (EFIC) in stroke research.
Area of Science:
- Neurology
- Clinical Research Ethics
- Stroke Medicine
Background:
- Exception from Informed Consent (EFIC) allows research enrollment without immediate patient/proxy consent under specific FDA regulations.
- Acute stroke trials are increasingly using EFIC to address enrollment challenges.
- This study investigated ischemic stroke survivors' views on hypothetical enrollment in trials using EFIC.
Purpose of the Study:
- To assess ischemic stroke survivors' opinions on hypothetical enrollment in acute stroke clinical trials without prior individual or proxy consent.
- To identify factors influencing patient agreement to EFIC in stroke research.
Main Methods:
- Prospective interviews with 460 ischemic stroke patients or proxies.
- Retrospective assessment at 2 years, asking participants about their hypothetical agreement to trial enrollment without consent.
- Logistic regression analysis to identify predictors of agreeable responses, including demographics and stroke severity.
Main Results:
- 194 patient/proxy responses were analyzed.
- 72-79% favorable responses for non-invasive procedures like chart review or blood draws.
- Lower agreement for medications (62.9%) and invasive strategies (59.8%).
- Older age, Black race, and female sex were associated with lower agreement for invasive procedures or medications.
Conclusions:
- A majority of ischemic stroke survivors expressed willingness to be enrolled in research under EFIC, though rates were lower than anticipated.
- Patient demographics, including age, race, and sex, significantly influence agreement to different levels of research invasiveness.
- Findings underscore the need to consider patient preferences when implementing EFIC in acute stroke research.
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